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Product Registration
QUONTER is led by many years of experience in their respective fields
We are a specialist in government regulations, registration and approvals for product importation and sale in Singapore and Malaysia.
Importing and exporting consumer and industrial goods is a complex trade challenge, not least due to legal and standard compliance requirements.
These requirements, for security, energy consumption, chemicals content, restricted substances are dependent on specific markets with their own national and international standards.
At QUONTER, we can provide you with the necessary services to make sure that your products comply with the requirements demanded from your Singapore market.
Our team of trade assistance experts are available and we have experience of regulations and standards on consumer and industrial goods across all industries and sectors.
Find out more about how we can help you with trade compliance and importing and exporting consumer and industrial goods.
Our core services can be divided into the categories:
Cosmetic Product
Cosmetic products are defined as products that are applied to the skin, hair, nails, lips or mouth for the purpose of cleaning, protecting, perfuming or enhancing appearance. To be classified as a cosmetic product allowable for import and sale in Singapore and Malaysia, the ingredients of the product would need to comply with the requirements, based on the ASEAN Cosmetic Directive.
The label of the product also needs to comply with the regulations, including information that must be displayed, listing of ingredients and allowable claims.
The cosmetic product must be submitted for notification with the Singapore health authorities before it can be sold. An online database is available for the public to check on the notification status of cosmetic products in Singapore and Malaysia.
Companies distributing cosmetic products are also required to report on any adverse events related to their products and to follow through with the corrective action, with may include product recalls.
Our Services
We can assist you with your cosmetic product classification, notification, import, warehousing and distribution. This would include checking the ingredients and label of the product and doing the notification. The person doing the notification will also be the responsible person for the product. We can act as your in-country representative to fulfill the role of the responsible person. We can also act as your in-country representative to monitor your products and handle adverse events if they occur.
Personal Care Products
Whilst personal care products may not be commonly referred to as cosmetics, if the product is applied to the skin, hair, nails, lips or mouth for the purpose of cleaning, protecting, perfuming or enhancing appearance, it is classified as a cosmetic product. This includes products like skincare, shampoo, toothpaste, hand and body wash.
Cosmetic products would require product notification and must meet the regulations governing cosmetic product, as detailed in the previous category.
Our Services
We can assist you with your personal care product classification, notification, import, warehousing and distribution. This would include checking the ingredients and label of the product and doing the notification. The person doing the notification will also be the responsible person for the product. We can act as your in-country representative to fulfill the role of the responsible person. We can also act as your in-country representative to monitor your products and handle adverse events if they occur.
Beauty/Wellness Device
Devices that are meant for beauty and wellness, meant to support general well-being without specific medical claims, are not considered as medical devices and do not require registration. However, if medical or treatment claims are made or the function of the device goes beyond general well-being, it may be classified as a medical device, which requires distribution licensing and product registration.
In addition, if the product is an electrical device with an AC adapter and/or 3 pin plug, it will require registration for the Consumer Protection (Safety Requirements) Registration Scheme.
Our Services
We can assist you with your beauty/wellness device classification, registration (if required), import, warehousing and distribution, act as your in-country representative and ensure compliance to the claims, advertisements and promotions regulations.
Health Supplement
Health supplements are not subject to approvals and licensing for import and sale in Singapore and Malaysia. However, the responsibility lie on the importer and distributor to ensure that their products meet the requirements for health supplements and the safety standards.
For a product to be classified as a health supplement, it needs to be a product that is used to supplement a diet, with benefits beyond those of normal nutrients, and to support or maintain the healthy functions of the human body. If it does not meet this criteria, the product may be classified as a food instead. A food product has different requirements from health supplement in terms of ingredients, presentation, allowable claims and product labelling. The presence of some ingredients and claims may also make the product into a medicine, Chinese proprietary medicine or traditional medicine.
Health supplements need to meet safety and quality standards in the areas of not containing prohibited ingredients, limits on toxic heavy metals, limits on microbes, limits on vitamin and minerals. They also have to adhere to the labelling and claims regulations and perform adverse events reporting when needed.
Our Services
We can assist you with your health supplement classification and to design the label and claims to meet the regulations for health supplements, as opposed to a health food or a medicine. We will evaluate if your product meets the required safety and quality standards, including checks on the ingredients. We can assist with the import, warehousing and distribution, and act as your in-country representative to monitor your products and handle adverse events if they occur
Health Food
Health food products are products that are typically consumed as part of a normal diet. Their presentation are in forms such as beverages, grains, loose powders, bars etc, as opposed to health supplements which are usually in forms such as capsules, softgels, tablets and pills.
Health supplements and health foods are managed by different government agencies in Singapore and Malaysia. As the products in the two categories may be in many ways similar, the classification can create confusion as the distinction between the two is sometimes not clear. Sometimes, the presentation and claims on the label may be the only thing separating one from the other.
Health foods and health supplements have different regulations and allowable claims. They are also governed by different legislative Acts. Health foods do not require registration for the import and sale in Singapore and Malaysia but they need to comply with the food regulations. Companies importing health food would also need a food import license, as well as a customs account. A locally incorporated company is needed to apply for the food import license and customs account.
Our Services
We can assist you with your health food classification and to design the label and claims to meet the regulations for health foods. We can assist with the application for the food import license and customs account. We can also assist with the import, warehousing and distribution, and act as your in-country representative for your customs account, to monitor your products and handle adverse events if they occur.
Chinese Proprietary Medicine
Chinese Proprietary Medicine (CPM) refers to a medicinal product that is in the form of a finished product, such as capsule or tablet, and where all the active ingredients are documented as traditional Chinese medicine. There is a government database of allowable active ingredients in CPM products that needs to be complied with. CPM products do not contain any chemically-defined isolated constituents as an active ingredient. Simply put, they do not contain any ‘Western’ active ingredients.
In order to import and distribute CPM products, a dealer’s license is needed and the products need to be registered. The dealer’s license comprise of the import, wholesale and/or manufacturing licenses.
CPM products need to adhere with the restrictions on prohibited ingredients, limits on naturally occurring substances, toxic heavy metals and microbes, labelling requirements and advertising and promotions regulations.
To apply for the dealer’s license to import and sell CPM products, a locally incorporated company is required. This company will need to submit its storage/warehouse layout plan, Good Distribution Practice standard operating procedure and Good Distribution Practice records. If the company outsource its logistics, then the logistics vendor will need to supply the necessary documents, as well as be subjected to the regular Good Distribution Practice audits by the health authority.
As CPM is considered a medicine, it is subjected to the Medicines Advertisements Regulations. A permit is required prior to any advertisement or sales promotion activities.
Our Services
We can assist you with your CPM classification and registration, dealer license application, set up of Good Distribution Practice, import, warehousing and distribution, act as your in-country registrant and liaison, and ensure compliance to the claims, advertisements and promotions regulations. The person doing the registration will also be the responsible person for the product. We can act as your in-country representative to fulfill the role of the responsible person. We can also act as your in-country representative to monitor your products and handle adverse events if they occur.
Traditional Medicine and Traditional Medicinal Material
In Singapore and Malaysia’s context, traditional medicines refer to Malay and Indian traditional medicinal products. They are finished products containing ingredients with uses documented in relevant traditional medicine references.
Traditional medicinal materials refer to medicinal materials from plants, animals or minerals in their natural states, or in processed forms that have undergone simple processing, such as cutting or drying. They are not in finished dosage forms, such as capsules or tablets.
Traditional medicines and traditional medicinal materials are not subjected to approvals and licensing before they can be imported and distributed in Singapore. The onus lie on the dealer to ensure the safety and quality of the products.
Traditional medicines and traditional medicinal materials need to adhere with the restrictions on prohibited ingredients, limits on naturally occurring substances, toxic heavy metals and microbes, labelling requirements and advertising and promotions regulations. As they are considered medicine, they are subjected to the Medicines Advertisements Regulations. A permit is required prior to any advertisement or sales promotion activities.
Our Services
We can assist you with your traditional medicine and traditional medicinal material classification and labelling. We will evaluate if your product meets the required safety and quality standards, including checks on the ingredients, labelling and claims. We can assist with the import, warehousing and distribution, apply for advertisement and sales promotion permits, act as your in-country representative to monitor your products and handle adverse events if they occur.
Medicine (Therapeutic Products)
Medicines (Therapeutic Products) are health products intended for use in humans for a therapeutic, preventive, palliative or diagnostic purpose. Therapeutic products can contain chemical or biologic substances as active ingredients. They require product registration in Singapore and Malaysia, and a dealer’s license.
A locally incorporated company is needed to apply for the dealer’s license. An importer’s license for therapeutic products and a wholesaler’s license for therapeutic products are required to import and wholesale therapeutic products respectively. The local company must also comply with the Good Distribution Practice standard to obtain the licenses.
Therapeutic products can be registered under the following forensic classifications. Prescription Only Medicines, Pharmacy Only Medicines and General Sale List. Prescription Only Medicines are products that can only be obtained from a doctor, a dentist or from a pharmacist with a prescription from a doctor or dentist. Pharmacy Only Medicines are products that can be obtained from a pharmacist at a retail pharmacy. General Sale List are products that can be freely obtained from any retailer.
A licensed pharmacist is required to be the responsible person to register Prescription Only Medicines and Pharmacy Only Medicines.
Our Services
We can assist with the preliminary work for the classification, registration and licensing, coordinating with other competent parties to do the necessary work. For General Sale List products, we can help with the registration. We can also assist with the establishment of the Good Distribution Practice standard operating procedure and to ensure compliance to the Medicines Advertisements Regulations.
Homoeopathic Medicine, Medicated Oil and Balm
Homoeopathic medicine, medicated oils and balms are not subjected to approvals and licensing before they can be imported and distributed in Singapore. The onus lie on the dealer to ensure the safety and quality of the products.
Homoeopathic medicine, medicated oils and balms need to adhere with the restrictions on prohibited ingredients, limits on toxic heavy metals and microbes, labelling requirements and advertising and promotions regulations. As they are considered medicine, they are subjected to the Medicines Advertisements Regulations. A permit is required prior to any advertisement or sales promotion activities.
Our Services
We can assist you with your homoeopathic medicine, medicated oils and balms classification and labelling. We will evaluate if your product meets the required safety and quality standards, including checks on the ingredients, labelling and claims. We can assist with the import, warehousing and distribution, apply for advertisement and sales promotion permits, act as your in-country representative to monitor your products and handle adverse events if they occur.
Product with AC Adapter or 3-Pin Plug
AC adapters and 3-pin plugs are controlled goods in Singapore and Malaysia, and are regulated by the Consumer Protection (Safety Requirements) Regulations. Under the regulations, controlled goods have to be registered and affixed with the Safety Mark before they can be sold in Singapore and Malaysia.
AC adapters and 3-pin plugs are considered medium risk controlled goods and would need to tested by a recognized testing laboratory to determine if they comply with the specified safety standard and to provide a Certificate of Conformity from a Conformity Assessment Body.
To import and sell controlled goods in Singapore and Malaysia, the supplier must also register to be a Registered Supplier. Only locally incorporated companies can become Registered Suppliers.
Our Services
We can assist with the registration of the controlled goods and Registered Supplier, as well as coordinate the product testing and acquisition of the needed certificates for registration. We can also assist with the import, warehousing and distribution of the products.
Electrical Product
As per the previous section, Product with AC Adapter or 3-Pin Plug, there are a total of 33 categories of Controlled Goods in Singapore that are regulated by the Consumer Protection (Safety Requirements) Regulations. Importers/distributors of these goods will need to register their products and to be Registered Suppliers.
The full list of Controlled Goods are Air Cooler; Fuse; Room Air-Conditioner; Table/Standing Lamp; AC Adapter; Audio and Video Products; Coffee Maker; Steam Boat and Similar Appliances; Decorative Lighting Chain; Fan; Gas Canister; Hair Care Appliances; Home Computer Systems; Iron, Isolating Transformer for Downlight Fitting; Kitchen Machines; Liquid Heating Appliances; Microwave Oven; Multi-Way Adapter; Toaster, Grill, Roaster, Hot Plate, Deep Fryer, Wok and Similar Appliances; Portable Socket Outlet; Residual Current Circuit Breaker; Rice Cooker; Stationary Cooking Appliances; Vacuum Cleaner; Washing Machine; 3-Pin Main Plug; Components of Liquefied Petroleum Gas System; Domestic Electric Wall Switch; Gas Cooking Appliances; Lamp Control Gear; Main Socket Outlet; Water Heater; Refrigerator.
Our Services
We can assist with the registration of the controlled goods and Registered Supplier, as well as coordinate the product testing and acquisition of the needed certificates for registration. We can also assist with the import, warehousing and distribution of the products.
Telecommunication Equipment
Importers, retailers, manufacturers intending to manufacture, import, let for hire, sell, or offer or possess for sale any telecommunication equipment must register for the Telecommunication Dealer’s License. One of the requirements is that it must be a locally incorporated business or company.
Telecommunication equipment must also be registered. Registration is a process in which a model of telecom equipment is registered with Info-communications Media Development Authority based on a Declaration of Conformity to Info-communications Media Development Authority standards, made by the supplier. The declaration shall be based on a certification or tests of the equipment by a local or foreign body recognised by Info-communications Media Development Authority.
Our Services
We can assist with the application of the telecommunication dealer’s license and the telecommunication equipment registration. We can also assist with the import, warehousing and distribution of the products.
Medical Device
Medical devices are devices used to diagnose, alleviate or treat a medical condition. They can also be devices to measure or monitor functions of the body e.g. thermometers, blood pressure monitors.
Medical devices are regulated in Singapore. Companies would need a dealer’s license to import and sell medical devices in Singapore. The dealer’s license includes the importer, wholesaler and manufacturer licenses. To obtain these licenses, an ISO 13485 certificate or a Good Distribution Practice for Medical Devices certificate may be required.
Medical devices may also require registration, depending on their risk level, which range from class A to D. Class A (low risk) medical devices are exempted from registration. Class B, C and D medical devices would require registration. For classes requiring registration, the time needed will depend on the evaluation routes. This can range from immediate upon submission to up to a year for full route evaluation for a high risk product. Quicker evaluation routes can be obtained if the medical devices have received prior approvals from the Singapore government’s overseas reference regulatory agencies, such as US FDA, EU NB, Australia TGA.
Our Services
We can assist you with your medical device classification and registration, dealer license application, set up of Good Distribution Practice, import, warehousing and distribution, act as your in-country registrant and liaison, and ensure compliance to the claims, advertisements and promotions regulations.
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